FDA 510(k) Application Details - K171827

Device Classification Name	Ventilator, Continuous, Non-Life-Supporting   More FDA Info for this Device
510(K) Number	K171827
Device Name	Ventilator, Continuous, Non-Life-Supporting
Applicant	SMD Manufacturing, LLC 2500 South State Street, Suite D224 Salt Lake City, UT 84115 US Other 510(k) Applications for this Company
Contact	Rian Wendling Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	MNS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2017
Decision Date	01/19/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review